The U.S. Food and Drug Administration (FDA) on June 24 issued marketing denial orders to JUUL Labs Inc. for all their products currently marketed in the United States, effectively banning the sale of JUUL products.
Effective immediately, NATSO members and all retailers must remove JUUL products from their shelves and stop selling these products or risk enforcement action.
JUUL promptly issued a statement that it is seeking a stay and “exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator.”
Products included in the FDA’s MDO are the JUUL device and four types of JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent and menthol flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent.
FDA said it intends to ensure compliance by distributors and retailers. The FDA also said that retailers should contact JUUL with any questions about products in their inventory.
Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are subject to enforcement action.
The denial orders pertain to the commercial distribution, importation and retail sales of the above JUUL products. They do not restrict individual consumer possession or use. FDA said it cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.
NATSO will continue to update members as more information becomes available.
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